A 2-night, 3-period, crossover study of ramelteon's efficacy and safety in older adults with chronic insomnia

Roth, Thomas; Seiden, David; Wang-Weigand, Sherry; Zhang, Jeffrey

doi:10.1185/030079907x178874

Cited by 111 publications

(91 citation statements)

References 32 publications

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“…[118][119][120][121] The overall quality of evidence from these studies was downgraded to very low due to substantial heterogeneity across studies, imprecision and potential publication bias. The overall evidence for ramelteon 8 mg. was weakly in favor of its effectiveness for the treatment of sleep onset disturbance only.…”

Section: Discussionmentioning

confidence: 99%

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0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Sateia

Buysse

Krystal

et al. 2017

Sleep

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Introduction:The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. Methods: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. Recommendations:The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of evidence in published data. Downgrading the quality of evidence for these treatments is predictable in GRADE, due to the funding source for most pharmacological clinical trials and the attendant risk of publication bias; the relatively small number of eligible trials for each individual agent; and the observed heterogeneity in the data. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources.1. We suggest that clinicians use suvorexant as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 2. We suggest that clinicians use eszopiclone as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 3. We suggest that clinicians use zaleplon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 4. We suggest that clinicians use zolpidem as a treatment for sleep onset and sleep maintenance in...

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Section: Discussionmentioning

confidence: 99%

“…[118][119][120][121] Subjects in all studies demonstrated chronic primary insomnia with associated daytime complaints. All studies required mean objective LPS of > 20 min on two nights of PSG screening.…”

Section: Discussionmentioning

confidence: 99%

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Sateia

Buysse

Krystal

et al. 2017

Sleep

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“…This indication is supported by self-report and polysomnographic studies showing that sleep onset is hastened along in a dosage range of 4 to 32 mg [59][60][61][62][63][64], although the indicated clinical dose is 8 mg. The incidence or insomnia increases in the elderly, and studies of remelteon have been conducted in elderly primary insomniacs, which show its efficacy in this population [60,61]. Tolerance to sleep onset-inducing effects did not develop in the 6-to 12-month studies that have been conducted [63,64].…”

Section: Efficacymentioning

confidence: 90%

Insomnia Pharmacotherapy

2012

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Summary The benzodiazepine receptor agonists (BzRAs) a melatonin receptor agonist and a histamine antagonist have all been approved as hypnotics. Beyond their differing mechanisms of action, they have differences in pharmacokinetics, and among the BzRAs differences in receptor subtype affinity and formulations, which provides the physician with broad options for tailoring therapy to each patient's specific needs. Consistent with their specific pharmacokinetics and formulations, these Food and Drug Administration-approved hypnotics have been shown to improve sleep with no evidence of tolerance development in long-term use. In addition, emerging data indicate these drugs also improve aspects of daytime function. Their side effects are either associated with the direct sedating effects of the drugs, doses greater than clinical doses, or a combination with alcohol or other sedating drugs. Anxiolytic BzRAs, sedating antidepressants and antipsychotics have been used off-label as hypnotics. However, in the absence of information regarding their dose range for efficacy and safety, their use as hypnotics is ill-advised.

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“…The efficacy and safety of ramelteon in treating insomnia have been proven in a number of clinical studies conducted on elderly insomniacs [Richardson et al 2009;Roth et al 2007;Zammit et al 2007;Erman et al 2006]. Ramelteon may have considerable therapeutic potential in treating the sleep problems including RBD seen in PD.…”

Section: Melatonin As a Therapeutic Agent In Parkinson's Diseasementioning

confidence: 99%

Therapeutic potential of melatonin and its analogs in Parkinson’s disease: focus on sleep and neuroprotection

Srinivasan¹,

Cardinali

Srinivasan

et al. 2011

Ther Adv Neurol Disord

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Sleep disorders constitute major nonmotor features of Parkinson's disease (PD) that have a substantial effect on patients' quality of life and can be related to the progression of the neurodegenerative disease. They can also serve as preclinical markers for PD, as it is the case for rapid eye movement (REM)-associated sleep behavior disorder (RBD). Although the etiology of sleep disorders in PD remains undefined, the assessment of the components of the circadian system, including melatonin secretion, could give therapeutically valuable insight on their pathophysiopathology. Melatonin is a regulator of the sleep/wake cycle and also acts as an effective antioxidant and mitochondrial function protector. A reduction in the expression of melatonin MT 1 and MT 2 receptors has been documented in the substantia nigra of PD patients. The efficacy of melatonin for preventing neuronal cell death and for ameliorating PD symptoms has been demonstrated in animal models of PD employing neurotoxins. A small number of controlled trials indicate that melatonin is useful in treating disturbed sleep in PD, in particular RBD. Whether melatonin and the recently developed melatonergic agents (ramelteon, tasimelteon, agomelatine) have therapeutic potential in PD is also discussed.

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A 2-night, 3-period, crossover study of ramelteon's efficacy and safety in older adults with chronic insomnia

Abstract: In older adults with chronic primary insomnia, ramelteon produced significant reductions in latency to persistent sleep and increases in total sleep time and sleep efficacy, and showed no evidence of adverse next-day psychomotor or cognitive effects.

Cited by 111 publications

References 32 publications

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Insomnia Pharmacotherapy

Therapeutic potential of melatonin and its analogs in Parkinson’s disease: focus on sleep and neuroprotection

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